The QMN Weekly Bulletin
Pharmaceuticals / GMPs / Inspections and Audits

FDA Hits Coram With Warning Letter for Sterile Drug Deficiencies

Oct. 9, 2015

The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products.

A Dec. 1, to Dec. 16, 2014, inspection resulted in a Form 483 after inspectors found that drug products were prepared, packed or held under unsanitary conditions, according to the Aug. 11 warning letter.

For example, an operator was observed resting gloved hands on the workbench surface of the ISO 5 laminar flow hood, and gloves were not appropriately sanitized. The facility also did not perform adequate cleaning and disinfection of the work surfaces.

Moreover, the firm failed to show that its laminar flow hood is able to provide adequate protection of the drug production area.

Coram said it is working with the FDA to ensure compliance.

Poor microbial contamination control is now a top Form 483 observation. Order our management report Manufacturing Sterile Products to Meet EU and FDA Guidelines and understand how U.S. and EU manufacturers must handle sterile processing!